Many therapeutic agents require an intravenous route for full potency and efficacy of treatment. Methods utilizing a nasal passageway are preferred to deliver such therapeutic agents under defined conditions. The delivery, through the absorption of the therapeutic agents through the membranes lining the nasal cavity and sinus regions, allows the rapid introduction and dispersion of aerosol or liquid agents. Combined with the ease of use and the relatively few and pain-free side effects, use of nasal passageways is a desirable route of administration.
The delivery of aerosols or liquids into the nasal passages has been described previously. Typically these devices call for the unidirectional delivery of these materials into the nasal passageways. In addition, many devices require the use of positive pressure for the delivery of drugs into the nasal passageways. For example, U.S. Pat. No. 4,969,578 relates to a pressurized dispensing apparatus for nasally administering medicinal products in aerosol form. The apparatus utilizes a pressurized dispensing container which, through positive pressure, dispenses an aerosalized medicinal agent through an outlet valve into the nasal passages of the patient. U.S. Pat. No. 5,906,198 provides for a unidirectional delivery device which utilizes dual air nozzles for spraying mist into the nasal passages of patients. U.S. Pat. No. 6,145,703 discloses a manual multi-dose spray applicator for dispensing a pharmaceutical liquid into the nasal passageways of a patient. As with the previous art disclosed, the '703 patent utilizes a unidirectional positive pressure means for delivering a metered amount of therapeutic agent into a patient's nasal passages.
Delivery of therapeutics in a powder-form to the nasal passageways of a patient is also possible using a positive pressure device. U.S. Pat. No. 5,702,362 ('362) describes a unidirectional nasal application for introducing powdery, pharmacologically active medicaments into the nasal passageways of a patient. The '362 device is similar to what has been described previously, in that positive pressure, supplied through a compressed air source, is used to generate a compressed air jet which transports a metered amount of powdered medicament through an outlet channel into a patient's nose.
Delivery of therapeutics for the reduction of mucus discharge is not without problems and side effects. Over the counter sprays containing allergy or sinus medications often have a wide variety of accompanying side effects, particularly excessive dryness of the nasal passageways.
Delivery of therapeutic aerosol, liquid or powdery agents is not the only use for nasal applicator devices. Devices which utilize larger volumes of liquid to rinse or lavage nasal passageways have been disclosed, and are also useful in the treatment of sinusitis and other nasal inflammatory conditions that require frequent rinsing of nasal passageways to remove foreign bodies trapped or embedded in the nasal cavities. Saline or lavage sprays are also useful in reducing the dryness accompanying sinus or allergy medications. U.S. Pat. No. 5,301,846 discloses a flexible spray bottle for delivery of larger volumes of liquid. The device utilizes a valve which allows air to flow into the bottle, reducing the possibility of secretions from the body cavity being sucked up through the spray opening into the fluid reservoir of the device. U.S. Pat. Nos. 5,899,878 ('878) and 6,135,358 ('358) disclose devices for irrigation of the nasal passageways using pressurized fluids generated from pressurized air containers ('358) or pump delivery devices ('878).
Although the above prior art disclose a means for ravaging or washing nasal cavities or the delivery of therapeutic agents to nasal passageways, one drawback of many devices is the discharge that is created upon dispensing of the solutions. It may be desirable to remove mucus secretions present in the nasal cavities and passageways, either present as a result of an infectious or allergic state, or as a reaction to the administered therapeutic agent. One solution for removing the fluid and mucus present in the nostrils is the use of gravity and physical expulsion of mucus contents. For example, U.S. Pat. No. 5,806,723 ('723) discloses a device to prepare and dispense lavaging solutions into the nasal cavities of a patient. Manual compression of the dispenser bottle, where saline solution is prepared, forces solution from the bottom of the bottle through the outlet tubing and into the patient's nostrils. The '723 patent also discloses a means for postural draining of solution from the nasal cavities. Postural draining is commenced by laying on one's back and holding the head slightly elevated. The process involves deep breathing and removal of expelling mucus as the head is rotated. Mucus removal is inefficient with this procedure, and requires an extensive investment in both time and physical effort. Recent patents have covered the use of outlet/pressure relief ports to both remove and aspirate nasal secretions after washing or lavaging of nasal passageways. U.S. Pat. No. Re. 36,070 ('070) discloses a device for washing nasal cavities which includes a compressed air injector, spray nozzle and a washing liquid. There is also a collection chamber for collecting the discharge arising from washing. However, the collection of this discharge is inefficient in that any forces on the discharge arise from the depressurization of a nasal cavity of unknown volume. The initial pressurization arises from the positive pressure used to form the atomizing spray combined with user technique to close the oral cavity by swallowing. This depressurization arises during the application or administration step. It does not define the volumes collected and does not permit a segregation of the collection step from the application step, thereby limiting the efficiency of the described device. European Patent Application No. 0 732 111 A2 discloses a micronized douche device for cleansing nasal and neighboring cavities. The device discloses an atomizing chamber, utilizing running water pressurized and dispensed with a compressed air injector. The secretions are removed through a discharge port provided at the bottom of the atomization chamber. Although the above invention provides a means for preventing the mixing of cleansing liquid with the cleansing solution that contains the removed secretions, like the '070 patent there is no segregation of the collection step from the application step, limiting the efficiency of the described device. In addition, removal of the cleansing liquid containing nasal cavity secretions is largely performed through gravity of the solution, falling inward into the bottom of the atomization chamber and out through a discharge port. European Patent Application No. EP 1 051 984 A2 provides for a vacuum means to remove mucus secretions, particularly from infants and others that cannot themselves physically expel mucus. In most situations, however, removal of mucus or nasal secretions is difficult in situations where the mucus or nasal secretions tightly adhere to the walls of the nasal passageways. The '984 patent lacks a means for dislodging or dispersal of such mucus or nasal secretions, making the system ineffective in removing mucus from the nasal passageways of a patient.
There remains a need for the efficient administration of liquids and aerosols to nasal passages and an efficient means for collecting the resulting discharge contained within a single hand-held device.